MAUDE Adverse Event Report: COVIDIEN PALINDROME - P(HSI) SP VT 33CM; DIALYSIS CATHETER

Model Number	8888133509P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 9/23/2016.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer reports while attempting to place the insertion stylet into the inner lumen of the catheter, the insertion stylet would not advance completely, the device would only allow a half insertion into the catheter.Therefore, the staff had to remove and open another palindrome catheter 33cm.There was nothing visibly wrong with the stylet; it was within the catheter, possibly an occlusion.
Additional Manufacturer Narrative
Submit date: 2/2/2017.A device history review (dhr) revealed no discrepancies that may have contributed this reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.Two samples were received for evaluation.One sample was opened and one sample was unopened.During a visual inspection, the opened kit revealed that one of the caps was missing and the stylet was bent.The stylets were passed through the lumens and as a result, the stylets easily passed through.The stylets were also measured and tested within specification.The reported issue was replicated when the stylet was incorrectly inserted into the lumen of the catheter.As per procedure, manufacturing performs an occlusion test in order to confirm if any material obstructs the tubing or if the slots were blocked.According to the visual evaluation, the catheter or the stylets did not reveal any problem related to the reported condition.The catheter was flushed successfully and no obstructions were identified.As per the instructions for use, load stylets fully into catheter and lock stylet hubs to lumen adapters.Ensure that the white flat side of the longer stylet containing the stylet side hole is oriented against the septum of the catheter lumen.It is possible that the clinician inadvertently placed the stylet in the incorrect position.A corrective action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% visual inspection, and visual acceptance sampling are performed in the plant) are in place to prevent non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME - P(HSI) SP VT 33CM
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• MDR Report Key: 5974805
• Report Number: 3009211636-2016-00409
• Device Sequence Number: 617398
• Product Code: MSD
• UDI-Device Identifier: 10884521157873
• UDI-Public: 011088452115787317180826101526600194
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888133509P
• Device Catalogue Number: 8888133509P
• Device Lot Number: 1511300105
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 02/07/2017
• Patient Sequence Number: 1